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Clinical Studies

          We are currently evaluating the effects of hormones on emotions, memory, and attention in patients with CAH.  This study can be completed in either one or two visits to the NIH Clinical Center in Bethesda, Maryland and includes:

                                  ▪Updated endocrine evaluation by Dr. Deborah Merke

                                  ▪Structured psychiatric interview

                                  ▪Questionnaires

                                  ▪MRI (does not involve radiation)

In order to participate in this study, volunteers must:

▪Have the classic form of CAH (21-hydroxylase deficiency)

▪Be between the ages of 9 to 25 years old

▪Not be on other medications besides CAH-related medications

Participants will be paid $350 for completion of the study and partial payment is available if only part of the study is completed.

For more information or to volunteer, please contact Julie Hardin or Liza Golan-Green at the NIH at (301) 451-9194. 

           The Division of Endocrinology at Children’s Hospital Los Angeles is currently recruiting subjects for a research study aimed at determining the stress-fighting ability in subjects with Non-classical Congenital adrenal hyperplasia (NCAH) and comparing these responses to those in subjects with Classical Congenital Adrenal Hyperplasia (CAH) and those in carriers of either disorder.  If you have NCAH, CAH or are a family member (parent or sibling) of someone with either disease, and are interested in participating in this study, please contact: Dr. Joshua May (323) 644-8705 or Dr. Mitchell Geffner (323) 669-7032.

            We are recruiting children with CAH who are 4-12 years old (bone age <14 years), are still growing, and have not yet started puberty.  Children will be enrolled in the study at the General Clinical Research Center at the University of North Carolina, Chapel Hill.

             Although cortisol replacement (hydrocortisone, prednisone, or dexamethasone, for example) and Florinef have virtually eliminated mortality, there are at least two reasons for continuing to try to perfect our treatment regimens: (1) the linear growth of children is suboptimal and the end result is an adult who is too short, and (2) over-treatment with glucocorticoids in children may increase  the risk of osteoporosis in later years.

Based on studies of the regulation of release of ACTH (that, in turn drives the production of hormones from the adrenal cortex), we have found that we can decrease the amount of ACTH using calcium channel blockers (medications typically used to treat high blood pressure, such as amlodipine). Amlodipine has been shown to be safe even in infants treated for a variety of medical reasons.

Our hypothesis is that addition of amlodipine will allow us to decrease the amount of glucocorticoid medication that your child is currently taking to control his/her CAH.  Such a decrease should translate into better growth and bone strength.  This new medication would be added to your child’s current CAH treatment program and evaluated in a double-blind/placebo-controlled crossover study.

For more information, please contact:      Karen Loechner, M.D./Ph.D.

(919) 216-5946 (pager)

(919) 966-4435 ext 224 (voice mail)

(919) 966-0428 (fax)

or

Roxanne Schock, CDE, Clinical Coordinator

(919) 966-0428 (voice mail)

 All visits, including laboratory testing, research medications, and parking will be paid for by this protocol.  Limited “off-site” testing at your local care provider may be available subject to IRB approval.  Travel funds available (please inquire for details). 

         Clinical researchers at the Center for CAH and Intersexuality are recruiting males with Congenital Adrenal Hyperplasia (CAH) and decreased spermatogenesis (process of forming sperm cells in the testes) for a NIH-sponsored research study performed at the University of Minnesota Medical School.  In CAH due to 21-hydroxylase deficiency (21-OHD), the body produces excess androgens (male hormones) because of the defect in the 21-OH enzyme.  In all humans, androgens are converted to estrogens through a process called aromatization.  In 21-OHD, the increased levels of androgens are aromatized/converted in glandular (ie testes) and extraglandular tissues and result in elevated estrogen levels.  Ideally the production of adrenal androgens is normalized in CAH patients by glucocorticoid replacement therapy.  However, even well controlled CAH patients still manifest the adverse effects (compromised final height, polycystic ovarian disease, male infertility, etc) of elevated androgens/estrogens.  We hypothesize that these chronically elevated estrogen levels negatively affect spermatogenesis in males with CAH.  The research study examines whether reducing the body’s estrogen level with an estrogen-reducing medication will improve overall fertility by reducing the negative effects of elevated estrogen levels.

Eligible Participants:         ● Males 16-50 years of age           ● Diagnosis of CAH    

Principal Investigator:  Kyriakie Sarafoglou, M.D.
Director, Center for CAH and Intersexuality
Division of Pediatric Endocrinology
Division of Genetics and Metabolismy
University of Minnesota Medical School 
General Clinical Research Center

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